This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | 2005-09-02 |
| US | K033999 | SEDLINE WITH FRONTAL PSI | 2004-02-06 |
| US | K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | 2002-10-08 |
| CA | 64168 | E.NET | Class II |
| CA | 64169 | BIOSENSOR EEG ELECTRODES | Class II |
| CA | 64371 | STARTER KIT FOR E.NET | Class II |